Safety Rates Drug Report: adverse events in 2016 Q3 - FDA prescription drugs adverse events in an open, searchable, online, public database

Drug Injury Quarter

Person who experienced the adverse event (patient)

Event ID	CASEID	CASEVERSION	I F COD	EVENT DT	MFR DT	INIT FDA DT	FDA DT	REPT COD	AUTH NUM	MFR NUM	MFR SNDR	LIT REF	AGE	AGE COD	AGE GRP	GNDR COD	E SUB	WT	WT COD	REPT DT	TO MFR	OCCP COD	REPORTER COUNTRY	OCCR COUNTRY
127633981	12763398	1	I	20160919	0	20160919	20160919	DIR	US-FDA-351050		FDA-CTU		67.00	YR		F	N	76.50000	KG	20160919	N	OT	US	US

Drug(s) used by person

Event ID	CASEID	DRUG SEQ	ROLE COD	DRUGNAME	PROD AI	VAL VBM	ROUTE	DOSE VBM	CUM DOSE CHR	CUM DOSE UNIT	DECHAL	RECHAL	LOT NUM	EXP DT	NDA NUM	DOSE AMT	DOSE UNIT	DOSE FORM	DOSE FREQ
127633981	12763398	1	PS	ACCUTANE	ISOTRETINOIN	1	Oral				N	Y			0	80	MG		QD

Indications of drugs used

Event ID	CASEID	INDI DRUG SEQ	INDI PT
127633981	12763398	1	Cyst

Outcome of event

Reactions reported

Event ID	CASEID	PT
127633981	12763398	Arthritis
127633981	12763398	Depression
127633981	12763398	Dyspepsia
127633981	12763398	Exercise tolerance decreased
127633981	12763398	Fatigue
127633981	12763398	Infection
127633981	12763398	Influenza like illness
127633981	12763398	Irritable bowel syndrome
127633981	12763398	Loss of libido
127633981	12763398	Neuropathy peripheral
127633981	12763398	Pain
127633981	12763398	Suicidal ideation
127633981	12763398	Visual impairment

Reporting Sources (this data is often not reported and may therefore be missing here)

Event ID	CASEID	RPSR COD
127633981	12763398	HP

Therapies reported

Event ID	CASEID	DSG DRUG SEQ	START DT	END DT	DUR	DUR COD
127633981	12763398	1			4	MON